Genta Incorporated announced that it has initiated a new clinical trial of tesetaxel in Korea as part of a comprehensive global initiative to replace standard taxanes as treatment for patients with advanced gastric cancer. In this trial, tesetaxel—the leading oral taxane in clinical development—will be combined with cisplatin and capecitabine (Xeloda; Hoffmann LaRoche, Inc.) The new trial will open at the Severance Hospital, Yonsei University, in Seoul, Korea with Dr. Sun Young Rha, MD PhD, acting as lead investigator.
The trial will be conducted in two phases in patients who have not previously received chemotherapy for advanced disease. The first phase will test full doses of cisplatin and capecitabine administered in combination with escalating doses of tesetaxel to determine safety. The second phase will examine the anticancer activity of the triple-drug combination. The primary endpoint of the second phase is progression-free survival at 6 months, with secondary endpoints of objective response, durable response, and disease control. The second phase will be conducted as a multicenter trial. Approximately 60 subjects will be enrolled in both phases of the study.
Genta has indicated that gastric cancer is a key initial target for registration studies with tesetaxel. Gastric cancer is the most prevalent tumor type in Korea and many other countries in East Asia.
The global standard of care for advanced gastric cancer is the combination of a platinum-containing drug (cisplatin, oxaliplatin, or carboplatin) plus a fluoropyrimidine (5-fluorouracil [5-FU], capecitabine, or S-l). One standard taxane (docetaxel; Taxotere(R) [Sanofi Aventis]) has been approved for 1st-line use in advanced gastric cancer when combined with cisplatin and 5-FU, having demonstrated improved progression-free survival in a randomized trial.
“While our earlier programs in gastric cancer have focused on 2nd-line use, this study represents our initial effort to document utility as a 1st-line agent,” said Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “We hope to demonstrate both activity and an improved side-effect profile that would allow us to rapidly advance tesetaxel into global pivotal studies in previously untreated patients with this devastating and increasingly common disease.”
Date: May 3, 2011
Source: Genta Incorporated